Effects of a Second-generation Mindfulness-based Intervention on Quality of Life, Pain Management, and Psycho-spiritual Wellbeing in Cancer Patients: A Randomised Controlled Trial

NCT06695234 | Recruiting

• 1 other identifier: ETH2324-3460
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Background This study explores the effectiveness of Meditation Awareness Training (MAT), a second-generation mindfulness-based intervention, in enhancing quality of life, pain management, and psycho-spiritual wellbeing among cancer patients. Existing research underscores the benefits of mindfulness-based interventions (MBIs) in alleviating psychological distress and improving overall quality of life for cancer patients. However, first-generation MBIs often exclude traditional Buddhist concepts such as impermanence and emptiness, Consequently, this can result in a superficial application that may not fully engage with the underlying causes of psychological distress or promote long-term spiritual and psychological growth. In contrast, second-generation MBIs like MAT aim to reintegrate these wisdom principles, potentially offering deeper psycho-spiritual benefits. By incorporating concepts like impermanence and emptiness, these interventions encourage a more holistic understanding and acceptance of life's challenges, fostering meaningful perspectives on illness and enhancing both spiritual and psychological wellbeing. This approach seeks to provide a more comprehensive and transformative experience for individuals, particularly those facing serious health challenges such as cancer. Aims The primary aim is to understand the effectiveness of MAT in individuals diagnosed with cancer. The study focuses on: Evaluating the impact of MAT on reducing psychological distress and enhancing pain management and quality of life. Exploring whether practising Buddhist wisdom concepts can foster meaningful perspectives on illness and life, thereby increasing spiritual wellbeing. Determining if MAT participation leads to the establishment of new daily practices and habits among cancer patients. Method The study employs a mixed-methods approach across three phases: Phase 1: A quantitative study using a randomised controlled trial (RCT) design. Participants will be divided into an intervention group (MAT) and a treatment-as-usual (TAU) control group. The effectiveness of MAT will be assessed using psychometric scales at multiple time points (baseline, week 4, week 9 post-intervention, and six-month follow-up). Importantly, participants in the TAU group will be offered the MAT intervention after the completion of the RCT, ensuring that all participants have access to the potential benefits of the intervention. Phase 2: A qualitative exploration using Interpretative Phenomenological Analysis (IPA) to gain insights into participants' lived experiences post-MAT intervention. This phase involves semi-structured interviews conducted at one month and six months post-intervention. Phase 3: A content analysis of diary entries collected from participants during the intervention to capture real-time reflections and experiences. Expected Outputs The study aims to provide empirical evidence on the effectiveness of MAT in improving psychological and spiritual wellbeing among cancer patients. It is expected to offer insights into how Buddhist wisdom can be integrated back into clinical mindfulness practices to enhance their impact. The findings could inform clinical practices and contribute to the development of more holistic mindfulness-based interventions for cancer care. Project Timelines Recruitment: Began in November 2024. Phase 1: The RCT is aimed to begin in the first quarter of 2025, with the intervention lasting 8 weeks, followed by data collection at specified time points. Phase 2: Conduct interviews at one month and six months post-intervention. Phase 3: Collect and analyse diary entries throughout the 8-week intervention. The entire study is structured to ensure comprehensive data collection and analysis, allowing for both quantitative and qualitative insights into the MAT intervention's impact on cancer patients.

Conditions

Cancer; Mindfulness-based Intervention; Meditation; Psychological Well-Being; Spiritual Wellbeing

Keywords

mindfulness-based intervention; Cancer; mental health; wellbeing; spiritual wellbeing; second-generation mindfulness-based intervention; RCT; oncology; psycho-oncology; meditation awareness training; MAT; MBI

Outcome Measures

Primary Outcomes (3)

• Depression, Anxiety, Stress scale (DASS)

  Assesses emotional states like depression, anxiety, and stress. 4-point likert scale with 0 'Does not apply to me at all' to 3 ' Applies all the time'. Higher total scores indicate higher levels of each sub category, anxiety, depression and stress.

  From enrolment, throughout the 8-week RCT, at 9 week follow up and at 6 months follow up

• McGill Pain Questionnaire Short-form

  Evaluates pain levels. Rates 15 pain descriptors on a scale of 0-3, where 0 = none, 1 = mild, 2 = moderate, and 3 = severe. Three pain scores are derived from the sum of the intensity rank values of the descriptors

  From enrolment, throughout the 8-week RCT, at 9 week follow up and at 6 months follow up

• The Functional Assessment of Chronic Illness Therapy - Spiritual Well-being Scale (FACIT-Sp)

  To measure spiritual wellbeing and overall quality of life.scored on a 5-point Likert scale, with 0 representing "not at all" and 4 representing "very much". Possible scores range from 0 to 48, with higher scores reflecting greater spiritual well-being and QOL.

  From enrolment, throughout the 8-week RCT, at 9 week follow up and at 6 months follow up

Secondary Outcomes (1)

• Five Facet Mindfulness Questionnaire (FFMQ)

  From enrolment, throughout the 8-week RCT, at 9 week follow up and at 6 months follow up

Study Arms (2)

MAT RCT study

EXPERIMENTAL

MAT vs Treatment-as- usual RCT

Behavioral: Meditation Awareness Training

Qualitative follow-up

NO INTERVENTION

Qualitative follow up of a sub-sample of those within the intervention group

Interventions

Meditation Awareness Training BEHAVIORAL

A second-generation mindfulness-based intervention that reincorporates Buddhist wisdom concepts into mindfulness-based intervention.

MAT RCT study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must be over the age of 18 and have received a cancer diagnosis, including any recurrences, within the last 24 months. Eligible diagnoses can range up to, but not exceed, stage 3 cancer at the start of the study.
• Participants to be available to attend weekly 2-hour sessions for 8 weeks
• Due to the nature of the online course, participants must have access to the Internet and use an electronic device capable of joining a video conference.

You may not qualify if:

• Those with a palliative diagnosis
• Those who may not speak English fluently.

Sponsors & Collaborators

• University of Derby: lead

Study Sites (1)

University of Derby

Derby, Derbyshire, De1, United Kingdom

RECRUITING

Related Publications (8)

• Shonin E, Van Gordon W, Griffiths MD. Meditation awareness training (MAT) for improved psychological well-being: a qualitative examination of participant experiences. J Relig Health. 2014 Jun;53(3):849-63. doi: 10.1007/s10943-013-9679-0.

  PMID: 23377964 BACKGROUND

• Van Gordon W, Shonin E, Griffiths MD. Towards a second generation of mindfulness-based interventions. Aust N Z J Psychiatry. 2015 Jul;49(7):591-2. doi: 10.1177/0004867415577437. Epub 2015 Mar 23. No abstract available.

  PMID: 25801660 BACKGROUND

• Van Gordon W, Shonin E, Dunn TJ, Garcia-Campayo J, Griffiths MD. Meditation awareness training for the treatment of fibromyalgia syndrome: A randomized controlled trial. Br J Health Psychol. 2017 Feb;22(1):186-206. doi: 10.1111/bjhp.12224. Epub 2016 Nov 25.

  PMID: 27885763 BACKGROUND

• Van Gordon W, Shonin E, Dunn TJ, Garcia-Campayo J, Demarzo MMP, Griffiths MD. Meditation awareness training for the treatment of workaholism: A controlled trial. J Behav Addict. 2017 Jun 1;6(2):212-220. doi: 10.1556/2006.6.2017.021. Epub 2017 Apr 20.

  PMID: 28425778 BACKGROUND

• Wells C, Malins S, Clarke S, Skorodzien I, Biswas S, Sweeney T, Moghaddam N, Levene J. Using smart-messaging to enhance mindfulness-based cognitive therapy for cancer patients: A mixed methods proof of concept evaluation. Psychooncology. 2020 Jan;29(1):212-219. doi: 10.1002/pon.5256. Epub 2019 Nov 25.

  PMID: 31654533 BACKGROUND

• Shennan C, Payne S, Fenlon D. What is the evidence for the use of mindfulness-based interventions in cancer care? A review. Psychooncology. 2011 Jul;20(7):681-97. doi: 10.1002/pon.1819. Epub 2010 Aug 4.

  PMID: 20690112 BACKGROUND

• Puchalski CM. Spirituality in the cancer trajectory. Ann Oncol. 2012 Apr;23 Suppl 3:49-55. doi: 10.1093/annonc/mds088.

  PMID: 22628416 BACKGROUND

• Chayadi E, Baes N, Kiropoulos L. The effects of mindfulness-based interventions on symptoms of depression, anxiety, and cancer-related fatigue in oncology patients: A systematic review and meta-analysis. PLoS One. 2022 Jul 14;17(7):e0269519. doi: 10.1371/journal.pone.0269519. eCollection 2022.

  PMID: 35834503 BACKGROUND

MeSH Terms

Conditions

Neoplasms; Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Central Study Contacts

Chloe Wells

CONTACT

+44 (0)1332 590500; c.wells2@derby.ac.uk

William Van Gordon

CONTACT

+44 (0)7375962731; w.vangordon@derby.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Student

Model Details: A 2 (Group: Intervention vs. Treatment-as-usual Control) x 4 (Time Points: baseline, week 4, week 9 post-intervention and six-month follow-up) design will be adopted. Those in TAU group will be offered the intervention once the study is complete. Qualitative interviews will be conducted with randomly selected participants from MAT intervention group, at one month follow-up and 6 month follow-up. Those in MAT group invited to submit weekly online diary entries throughout the intervention.

Study Record Dates

• First Submitted: November 13, 2024
• First Posted: November 19, 2024
• Study Start: November 1, 2024
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: November 19, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Up to seven years post publication
• Access Criteria: Access to the data will be granted upon request to researchers who provide a detailed proposal outlining the intended use of the data. An ethics committee will review proposals to ensure they align with ethical standards, particularly regarding participant confidentiality and the intended use of the data for advancing research in mindfulness-based intervention

Locations

GB (1)